Regulators in most medical device markets require registrants to meet post-market surveillance (PMS) obligations to maintain compliance. However, PMS rules can vary between different medical device markets, requiring manufacturers to develop tailored rather than one-size-fits-all approaches.
With deep expertise in post-market surveillance requirements, Emergo is equipped to act as your compliance partner long after your device goes on the market. We can help you design and implement a PMS system that meets requirements in multiple markets and navigate regulatory challenges throughout the device lifecycle.
We can help determine when incidents are reportable, and help you complete vigilance reports on time and in compliance with local requirements.
Multi-disciplinary post-market risk management consulting and support
Our experts have in-depth product knowledge covering a wide range of functional and technical disciplines that support medical device post-market risk management activities. From designing and executing a post-market clinical follow-up (PMCF) study to conducting a root cause analysis of your device in response to an adverse event, we collaborate with you to deliver a proprietary solution to your post-market needs.